4.應(yīng)當(dāng)建立健全產(chǎn)品質(zhì)量管理制度，包括采購(gòu)、進(jìn)貨驗(yàn)收、倉(cāng)儲(chǔ)保管、出庫(kù)復(fù)核、質(zhì)量跟蹤和不良事件的報(bào)告制度等；

5.應(yīng)當(dāng)具有與其經(jīng)營(yíng)的醫(yī)療器械產(chǎn)品相適應(yīng)的技術(shù)培訓(xùn)和售后服務(wù)的能力，或者約定由第三方提供技術(shù)支持；

6.經(jīng)營(yíng)無(wú)菌和植入類(lèi)產(chǎn)品的公司需建立計(jì)算機(jī)管理系統(tǒng)及計(jì)算機(jī)管理制度，能夠保證產(chǎn)品從購(gòu)進(jìn)到銷(xiāo)售整個(gè)過(guò)程的有效質(zhì)量跟蹤和追溯。

申請(qǐng)醫(yī)療器械經(jīng)營(yíng)許可證所需材料：

醫(yī)療器械經(jīng)營(yíng)許可證辦理依據(jù)《北京市實(shí)施細(xì)則（2017年修訂版）》，具體提交材料如下：

1．《 醫(yī)療器械經(jīng)營(yíng)許可申請(qǐng)表》（原件1份）

2．《營(yíng)業(yè)執(zhí)照》復(fù)印件（交驗(yàn)原件）；（復(fù)印件1份）

3．法定代表人、企業(yè)負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人的身份證明（查驗(yàn)原件）、學(xué)歷或者職稱(chēng)證明復(fù)印件（對(duì)于統(tǒng)一采購(gòu)渠道，采取連鎖經(jīng)營(yíng)的非法人零售企業(yè)，提供連鎖企業(yè)總部質(zhì)量負(fù)責(zé)人身份證明、學(xué)歷或者職稱(chēng)證明復(fù)印件）；（交驗(yàn)原件） （復(fù)印件共3份）

4．企業(yè)基本情況（原件1份）。（內(nèi)容包含：組織機(jī)構(gòu)與部門(mén)設(shè)置說(shuō)明、經(jīng)營(yíng)場(chǎng)所、庫(kù)房的地理位置圖、平面圖（注明面積）、庫(kù)房的產(chǎn)權(quán)證明及使用權(quán)證明復(fù)印件、（委托貯存的，應(yīng)提交經(jīng)營(yíng)場(chǎng)所地理位置圖、平面圖（注明面積）和與被委托方簽署的書(shū)面協(xié)議復(fù)印件、被委托方的《醫(yī)療器械經(jīng)營(yíng)許可證》復(fù)印件）

s shall establish a computer management system and a computer management system to ensure the effective tracking and traceability of the whole process of products from purchase to sales. Materials required for applying for the Medical Device Business License: The medical device business license is handled according to the Implementation Rules of Beijing Municipality (2017 Revision), and the specific materials are as follows: 1. Application Form for Business License of Medical Device (1 original) 2. Copy of Business License (original copy for inspection); (1 copy) 3. The legal representative, head of the enterprise, of the identity certificate (check the original), certificate or title certificate copy (for unified purchasing channels, take the chain enterprise head certificate, certificate or copy of the title certificate); (submit the original) (copy of 3 copies) 4. Basic information of the enterprise (1 original copy).(Content includes: organization and department set instructions, premises, ware